Per40-44 - Hematology Quality Control Program

Patient Safety Monitoring in International Laboratories (SMILE)
Quality Management in
Hematology Laboratory.
By Heidi Hanes
1
Objectives
• At the end of this presentation should be able to:
Recognize the four components of Quality
Assurance.
Recognize how to troubleshoot problems.
Develop own policy for all aspect of quality
assurance.
Understand what is necessary to undertake a
program of Quality Management in Hematology
Laboratory.
3
Quality Management includes

• Standardization
• Pre Analytical Control
• Post Analytical Control
• Analytical Control
Internal Quality Control
External Quality Assessment
4
5
Standardization
• Collaboration between groups.
• Standard Operating Procedures
• Problem solving for unsatisfactory

performance
• Test selection
6
PRE-ANALYTICAL
CONTROL
7
Understanding functionality of
your instrument:
• principles of operation
• startup or daily checks
• shutdown procedure
• normal sights and sounds of the
instrument
• familiarize staff to troubleshooting
manual
8
Hematology Subsystems
• Consist of 3 subsystems.
 Electronic
 Fluidic
 Pneumatics (pressure and vacuums)
 Hydraulics (liquids)
 Reagent
9
Proper Specimen Collection

• Analyze only specimens that were
properly collected and stored.
Correct Tube
Correct amount of specimen in tube
Proper mixing
Cleanliness of puncture area
Storage
10
Exercise 1
11
Pre-Analytical Example 1
21-May-2015
13:45
WBC 0.05 x 10^3/L PASS
RBC 0.00 x 10^6/L PASS
Hgb 0.00 x g/dl PASS
Plt 10.0 x 10^3/U FAILED
12
Repeat Background
21-May-2015
14:00
Plt 15.0 x 10^3/U FAILED
13
Corrective Action
• Check when reagent(s) last changed.

• Change the most recently added
reagent.
• If none recently added change the
diluent.
• Rerun start-up
14
Repeat Background
21-May-2015
14:30
Plt 2.0 x 10^3/U PASS
15
Causes for high background
• The uptake tubing got contaminated.

• Reagent agitated before connecting
to instrument.
• Dried reagent spills or leaks.
16
Copy from Coulter LH780 Manual

17
All parameters have a “P” code
Partial Aspiration
18
What can give this code?
• Sample could be clotted.

• Hemoglobin is less than 4 g/dl
• Sample volume too low.
• The blood detector was turned off.
• Check your instrument manual.
19
Other Corrective Steps
• Troubleshoot for leaks, kinks or plugs

along the sample flow path.
• Ensure the aspiration lines are clean.
• Check for needle plugs.
• Call Service Hot Line
20
Get a 30psi Pressure High Error
21
Solutions
• Find the 30psi regulator and adjust to 30
+/-0.2 psi.
• Rerun several bloods and compare to see
if any difference.
• If unable to adjust or error occurs again
call Technical Hot line.
22
23
Post-Analytical Control
Understanding your
instrument results:
24
Flags
• Can be a letter or symbol that appears to
right of the result.
Manufacturer controlled
Aspiration, Linearity, interference
Laboratory controlled
Critical range
Decision rules
25
26
Codes
• Symbols that appear in place of results
Indicate beyond reportable range +++++
Vote-out of aperture
Unable to calculate result
Clogged flow cell
27
Messages
• Usually manufacturer messages
• Indicate possible abnormal cells,
clumping, agglutination
• Used to decide on reporting of instrument
vs manual differential or verification of
measured results.
28
I
W
29
Patient Results
• Are the results consistent with the
patient’s condition?
• Delta checks
Can be set on instrument or LIS.
Checks against previous result.
Value set by laboratory.
30
H & H Check/Difference
• Hgb x 3 = HCT +/- 3%

• If > +/-3 can indicate a problem.
Instrument
Sample
31
Exercise 2
32
Post Analytical Example 1

Laboratory Results Instrument Differential
WBC - 8,900/uL Neutrophil % - 52.5%
RBC - 4,460,000/uL Lymphocyte % - 35.2%
Hgb -13.4 g/dl Monocyte % - 10.4%
HCT- 40.7% Eosinophil % - 1.4%
Platelets - 56,000/ul Basophil % - 0.5%
MCV - 91.1.1fl Flags
MCH - 29.9pg WBC interference (*)
MCHC - 32.8g/dl Micro/Fragmented RBC
Giant Platelets
RDW - 23.1%
R (Review)-code on
Platelets
Platelet Clumps
33
34
35

Laboratory Results
WBC - 8,500/uL Instrument Differential
RBC - 4,870,000/uL Neutrophil% - 60.9%
Hgb - 16.4 g/dl Lymphocyte % - 28.7%
HCT - 43.5% Monocyte % - 8.2%
Platelets - 356,000/ul Eosinophil% - 2.0%
MCV - 89.5 fl Basophil% - 0.2%
MCH - 23.6 pg Flags
H-H difference check
MCHC - 37.7 g/dl
 Alert (aH) on the MCHC
RDW -12.5%
Spun HCT – 44%
36
What is the Explanation ?

Spun Plasma
• The MCHC is > 36
• The spun hematocrit matches the
instrument
• It would appear that the Hgb is
incorrect
• Lipemia will falsely increase the
hemoglobin result
• Follow laboratory policy for lipemic
samples
37

Laboratory Result 1 Laboratory Result 2
WBC - 8,500/uL WBC – 8,300/uL
RBC - 4,870,000/uL RBC – 4,000,000/uL
Hgb - 16.4 g/dl Hgb – 16.2 g/dl
HCT – 48.2% HCT – 36.0%
Platelets - 356,000/ul Platelets – 340,000/uL
MCV - 89.5 fl MCV – 90.0 fl
MCH - 33.7 pg MCH – 40.5 pg
MCHC – 34.0 g/dl MCHC – 45.0 g/dl
No flags H-H difference check
Delta Check on HCT
and MCHC
38
39

Laboratory Result 1 Laboratory Result 2
WBC – 6,300/uL WBC – 6,800/uL
RBC – 2,321,000/uL RBC –3,475,000 /uL
Hgb – 6.5 g/dl Hgb – 9.5 g/dl
HCT – 19.5% HCT – 28.5%
Platelets - 250,000/ul Platelets – 240,000/uL
MCV - 75 fl MCV – 82 fl
MCH – 28.0 pg MCH – 29.0pg
MCHC – 33.3.0 g/dl MCHC – 34.3.0 g/dl
RDW – 9.8 RDW – 13.4
Delta Check on Hgb,
HCT, and MCV
40
41
42
43
Analytical Control
• Internal Quality Control

• External Quality Assessment
44
INTERNAL QUALITY
CONTROL
45
Internal Quality Control includes
• Daily control specimen

Commercial Control
Patient Control
• XB Analysis – Moving Average
• Correlation/Comparison System
• Policy- QC and Troubleshooting
46
Internal Quality Control
Commercial Controls
47
Commercial Controls
• Assayed vs Non-assayed
• Introducing New QC Lot
• Establishing QC Ranges
48
Lot–To-Lot Correlations
1. Set up new QC files for each control level of the new lot.
2. Verify the new lot by running each level of control three times
in its respective file.
3. Ensure that the mean values of the control runs fall within the
ranges published on the manufacturer assay.
4. Run each level twice a day for 3-5 days to calculate new
mean values for each analyte.
5. Compare the calculated mean values for each level to the
range specified on the manufacturer assay sheet.
6. If the calculated mean is within range, enter it as the
expected mean.
49
Establishing Means and

Standard Deviations
1. Analyze the control(s) a minimum of 20 times across several
days.
2. Take the average of these runs.
3. The average should be within the range state on the assay
sheet.
4. Calculate a two Standard Deviation range from your results.
5. Incorporate this SD range around your new mean and
monitor.
6. The mean and SD values should be periodically recalculated
during the life of the new lot.
50
Factors to Consider for Means

• Some hematology parameters, such as MCV,
Platelets and RBC will start to change over
time.
• MCV will increase.
• RBC values can decrease.
• Platelets values will increase.
• Mean, SD, and CV should be evaluated
monthly.
51
Exercise 3
52
QC Example 1
• Know variation of mean 2 fl
• Initial MCV mean – 84 fl
• Historical 2 SD – +/- 4 fl
• Use half known variation accommodate change
 1 fl
• What should the mean be?
 85
• Established range – 81-89 fl
• Cumulative mean at end of product life should be 85.
53
81 80 82 84 85 86 83 82 81 83 84 85 83 85 84 83 81 83 85 84 83 85 86 85 84 85 86 83 85 85 84 85 86 86 85 86 85 86 87 86 87 86 87 88 88 89 85 86 87 88 89 86 87 88 89 90 88 89 85.20
54
QC Example 2
• Manufacturer RBC mean – 2.29 x 106
• Manufacturer RBC Range – 2.18-2.40 x 106
• Calculated RBC mean – 2.35 x 106
• Is this mean valid?
• Our 2SD = 0.15 x 106
• Calculated RBC range – 2.20-2.50 x 106
• Yes mean within the expected range.
55
QC Example 3
• Manufacturer Platelet mean – 528 x 103
• Manufacturer Platelet Range – 407- 649x 103
• Calculated Platelet mean – 402x 103
• Is this mean valid?
• No below the expected range.
56
Commercial Control Monitoring
Levey-Jennings Charts
57
Levey-Jennings QC Charts
58
Trend
59
Shift
60
Bias
61
62
QC Policy
• Each laboratory should adopt QC rules.

• Establish policy/corrective action for
controls that are “Out”.
Documentation is important.
• Establish policy for Trends, bias and shifts.
• Establish when calibration are required.
63
64
65
Policy Example
• If control out +/-2SD and a second Westgard rule is also
seen
 Rerun the control.
 If another vial of control is available use it.
 No more than 2 control reruns from same vial or new
vial should be made.
 If control still out begin troubleshooting do not report
patient results.
Check maintenance log
Check reagent
Check calibration date
66
Troubleshooting Guideline
• Should have a policy on how to perform
trouble shooting for out of range results.
Instrument vs sample problem
Resolve problem before running patients
• Can create a checklist .
• Can also include a Corrective Action
Flowchart .
67
Exercises 4
68
LJ Example 1
69
LJ Example 2
70
LJ Example 3
71
LJ Exercise 4
72
LJ Example 5
73
Retained Patient Controls
74
Retained Patient Control

• Two-three patient samples with specific
parameters.
• Can be used over a 24 hour period.
• Cost efficient.
• Can be used to detect systematic error.
• Transferable between instruments and
modes.
75
Sample Type WBC HGB
Control 1 5.0-10.0 x 103/mm3 12.0-15.0 mg/dL
Control 2 10.0-15.0 x103 /mm3 7.0-10.0 mg/dL
• Parameter Control 1 Control 2
WBC ± 0.6 ± 1.4

RBC ± 0.14 ± 0.14
HGB ± 0.3 ± 0.3
HCT ± 2.0 ± 2.0
MCV ± 2.0 ± 2.0
PLT ± 40.0 ± 40.0
• Just like commercial controls should have

policy for “Outliners and corrective action.
76
Control Decisions
If Patient Control outside of acceptable range rerun
• IF • THEN
– Acceptable – Proceed with patients
– Still out – Use back-up method
– Results still the same – Sample deterioration
on back-up instrument proceed with patients
– Results acceptable on – Indicate instrument
problem, use back-up
backup instrument
instrument.
– Inform QC tech or
supervisor
77
Exercises 5
78
Patient QC Example 1
Original Result Scheduled rerun
• WBC – 5.5 x 103 /ul • WBC- 5.9 x 103 /ul
• RBC – 3.554 x 106 /ul • RBC – 3.354 x 106 /ul
• Hgb – 12.4 g/dl • 12.0
• Hct – 36.5 % • 33.5 %
• MCV – 85 fl • 84 fl
• Plat – 250.0 x 103 /ul • 268.0 x 103 /ul
79
Original Result Repeat Result
• WBC – 5.5 x 103 /ul • WBC- 5.8 x 103 /ul
• RBC – 3.554 x 106 /ul • RBC – 3.254 x 106 /ul
• Hgb – 12.4 g/dl • 12.0
• Hct – 36.5 % • 33.0 %
• MCV – 85 fl • 85 fl
• Plat – 250.0 x 103 /ul • 260.0 x 103 /ul
80
Original Result Back-up Result
• WBC – 5.5 x 103 /ul • WBC- 5.8 x 103 /ul
• RBC – 3.554 x 106 /ul • RBC – 3.354 x 106 /ul
• Hgb – 12.4 g/dl • 12.1
• Hct – 36.5 % • 33.5 %
• MCV – 85 fl • 85 fl
• Plat – 250.0 x 103 /ul • 265.0 x 103 /ul
81
XB- Moving Average
82
XB – Moving Averages
• Cost effective quality control method.
• Allows for continuous monitoring of system
performance.
• Uses patient samples in conjunction with
other controls.
• Created by Brian S Bull.
• Algorithm evaluates RBC indices.
• Must run either 100/day or 400/week
83
How to Set Target Values

• Start with Bull’s values:
MCV = 89.5, MCH=30.5, MCHC=34.0
• Run 400 bloods or one week’s worth
• Calculate the mean (target value), SD and %CV
• %CV has to be </= 1.5%
• Target value should be within 3% of Bull’s
• The values must be physiologically possible
• Upper and lower range set at 5% of target
84
Reason Why Moving Average

to be Out
• Non-random population
• Instrument problem
• Calibration
85
Exercises 6
86
Parameters used in XB
• MCV – usually direct measurement
• MCH = Hgb x 10/RBC
• MCHC = Hgb x 100 / HCT (Usually Calculate)

HCT = RBC x MCV/10
87
How to troubleshoot with XB

• MCV
 Involves RBC aperture
 Tell if problem with sizing or flow problem
• MCH
 Involves Hemoglobin sample which is part of WBC
sample
 Involves RBC count
• MCHC
 Involves all three parameters.
88
XB Troubleshooting Policy
• Moving Average Acceptability
If Then
Moving average parameters agree within the established Proceed with test of patient samples.
limits set
If 5-6 batches fall outside the limit set and cannot be Hold testing of patient samples and run on backup until
explained investigation complete
• Investigation
89
Example 1
90
MCV
MCH
MCHC
91
Yes Yes Yes
Yes
No
Yes Yes
No
No
92
Indices Pattern: MCV MCH MCHC OK

• Make the aperture • Increase MCV
diameter smaller
• Decrease number • MCH = Hgb x 10/RBC

RBC getting through  Increase MCH
• MCHC = Hgb x 1000
RBC x MCV
 No change
93
Example 2
94
MCV
MCH
MCHC
95
Yes
Hgb
RBC Yes
Yes
No No
Yes
96
Indices Pattern: MCV OK MCH MCHC

• Bubbles in cuvette • MCH = Hgb x 10/RBC
Increase Blank  Decrease MCH
Reading • MCHC = Hgb x 1000
Decrease Hgb RBC x MCV
 Decrease MCHC
• MCV
 No change
• Possible H&H Check
97
Indices Pattern: MCV OK MCH MCHC

• Low vacuum • MCH = Hgb x 10/RBC
increased  Decrease MCH
Increase RBC • MCHC = Hgb x 1000
RBC x MCV
 Decrease MCHC
• MCV
 No change
• Possible H&H Check
98
Example 3
99
MCV
MCH
MCHC
100
Yes
Yes Yes
No No
101
Indices Pattern: MCV MCH OK MCHC

• Frozen Diluent • MCV
Thawed will  Increased
separate into two • MCH = Hgb x
layers 10/RBC
Hypotonic on top
 No change
Hypertonic on
• MCHC = Hgb x 1000
bottom
When get to top RBC x MCV
layer cause RBC  Decrease MCHC
swell
102
Correlation/Comparison
• Blood count to blood film
• Blood count changes to clinical events
• Instrument to instrument
103
Factors to Consider with IQC

• Type of instrument – if fully automated.
• The size of the lab.
• The level of training of your staff.
• The number of specimens handled each
day.
• Dayshift vs 24 hour laboratory.
• Country’s own regulations.
• Accreditation requirements.
104
IQC Recommendations
• A three level commercial control along with a
retained patient control.
• If patient numbers permits add XB to IQC
• Commercial controls
Two levels at beginning, middle and end of
shift
• Retained Patient Controls
At equal times between commercial controls
105
QC Schedule Example
• 8:00 AM Commercial Controls level 1 and 2

10:30 AM Retained Patient Controls
• 1:00 PM Commercial controls Level 2 and 3
3:30 PM Retained Patient Controls
• 6:00 PM Commercial Controls Level 1 and 3
106
107
EXTERNAL QUALITY
CONTROL
108
Why need EQA
• To detect errors not detectable by internal

controls.
• Ensures harmonization between
laboratories.
• Used recognize systematic errors.
Lab Result – Mean/SD = SDI
109
• Bias –two or more specimen’s SDI are >

2.0
• Shifts –All specimen’s SDI in single event
> 1.0 on opposite side of previous event
• Trends – SDIs increase progressively in
one direction for three EQA events away
from mean
110
SDI Interpretation
• <1.0 = satisfactory performance

• 1.0-2.0 = still acceptable but borderline
• 2.0-3.0 = requires review of techniques
and check on calibration
• >3.0 = defect requiring urgent investigation
111
Exercises
7
112
EQA Example 1
MCV
113
EQA Example 2
Instrument Differential
114
115

INVESTIGATIVE ACTIONS AND ROOT CAUSE: Briefly discuss what actions were taken in this
investigation and what you believe is the possible cause.
1. We checked to find out whether there were clerical errors and found out that there was
none.
2. After replacing the flow cell, the EQA specimen which failed were re-run and all were
within range.
The cause of the EQA failure was a faulty flow cell in the CBC/Differential Analyzer.
This was confirmed because after replacing the flow cell the EQA samples were re-run, all
of the values that had previously failed now fell within acceptable limits of intended
results.
116
EQA Example 3
117
CV
is
118
EQA Example 4
RBC Problem
119
120
EQA Example 5
Multiple Analyte Problems
121
122
123
Summary and Conclusion

• Standardization
• Pre Analytic Control
• Post Analytic Control
• Analytical Control
Internal Quality Control
External Quality Assessment
124
Questions and Answers?
125
References
• Quality Control (QC) Information and Troubleshooting
Guide – Hematology – Beckman Coulter
• The use of retained patient specimens for hematology
quality control. Hackney JR, Cembrowski GS
• An optimized quality control procedure for hematology
analyzers with the use of retained patient specimens.
Cembrowski GS, Lunetzky ES, Patrick CC, Wilson MK
• Establishing Quality Control Means and Standard
Deviation for Hematology Instrument, Streck
• Quality Assurance in Hematology, WHO
126

Per40-44 - Hematology Quality Control Program

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Per40-44 - Hematology Quality Control Program

Uploaded by

Copyright:

Available Formats

Patient Safety Monitoring in International Laboratories (SMILE)

Quality Management includes

• Standard Operating Procedures

• Problem solving for unsatisfactory

Proper Specimen Collection

WBC 0.05 x 10^3/L PASS

RBC 0.00 x 10^6/L PASS

Hgb 0.00 x g/dl PASS

Plt 10.0 x 10^3/U FAILED

WBC 0.05 x 10^3/L PASS

RBC 0.00 x 10^6/L PASS

Hgb 0.00 x g/dl PASS

Plt 15.0 x 10^3/U FAILED

• Check when reagent(s) last changed.

RBC 0.00 x 10^6/L PASS

Hgb 0.00 x g/dl PASS

Plt 2.0 x 10^3/U PASS

Causes for high background

• The uptake tubing got contaminated.

Copy from Coulter LH780 Manual

What can give this code?

• Sample could be clotted.

Other Corrective Steps

• Troubleshoot for leaks, kinks or plugs

Get a 30psi Pressure High Error

• Hgb x 3 = HCT +/- 3%

Post Analytical Example 1

Post Analytical Example 2

What is the Explanation ?

Post Analytical Example 3

Post Analytical Example 4

• Internal Quality Control

Internal Quality Control includes

• Daily control specimen

Internal Quality Control

• Introducing New QC Lot

Establishing Means and

Factors to Consider for Means

• Each laboratory should adopt QC rules.

Internal Quality Control

Retained Patient Controls

Retained Patient Control

• Parameter Control 1 Control 2

WBC ± 0.6 ± 1.4

• Just like commercial controls should have

Internal Quality Control

XB- Moving Average

How to Set Target Values

Reason Why Moving Average

• MCH = Hgb x 10/RBC

• MCHC = Hgb x 100 / HCT (Usually Calculate)

How to troubleshoot with XB

Indices Pattern: MCV MCH MCHC OK

• Decrease number • MCH = Hgb x 10/RBC

Indices Pattern: MCV OK MCH MCHC

Indices Pattern: MCV OK MCH MCHC

Indices Pattern: MCV MCH OK MCHC

• Blood count to blood film

• Blood count changes to clinical events

Factors to Consider with IQC

• 8:00 AM Commercial Controls level 1 and 2

Why need EQA